Description
Job Location: Cambridge, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Director
Company Overview
At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics®, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients’ lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact.
Key Responsibilities
Your Role
Merus is seeking a Sr/Director, Pharmacovigilance (PV) Scientist who will be accountable for overall PV science support for pharmacovigilance department at Merus, which includes working in collaboration with the Global Safety Physician(s) to lead signal detection activities conducted in the safety governance model within the company. This includes review of adverse event and laboratory data as applicable, Serious Adverse Events reported in clinical trials, and literature relevant to the products assigned. The ideal candidate will play a critical role in further developing and enhancing PV processes and procedures relative to the PV scientist role.
The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge, MA office location and will be expected to travel to the office as needed for meetings and other business needs.
In This Role You Will
- Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products at Merus.
- Works in collaboration with the Global Safety Physician to develop, maintain, oversee, and execute comprehensive safety surveillance and signal detection plan for assigned products.
- Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
- Leads collaboration with Safety and Clinical representatives; authors Reference Safety Information (RSI) for assigned products based on developed benefit-risk profile.
- Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs , PSURs , DSURs ) according to processes and timelines.
- Authors/provides strategic leadership to regulatory submissions for new products , formulations or indications (NDA/BLA , MAA ), in partnership with Global Safety Physician and other functional experts.
- Contributes to pharmacovigilance and risk management planning for Merus products including preparation of safety aspects Risk Management Plans with applicable License Partners as appropriate; REMS if applicable.
- Supports multidisciplinary Safety Management Team; escalates all relevant safety matters appropriate decision-making level providing proposals solutions based analysis available information collaboration Global Safety Physician .
- Additional projects as assigned
- Participates PV audits inspections CAPA activities required
- Contributes drug safety departmental policies procedures that address signal detection management , safety governance periodic reporting applicable.
Skills Knowledge Expertise
Your Profile
We Are Looking For a Candidate With
- Bachelor’s degree sciences/pharmacy/nursing degree related field Bachelor’s degree health-care related discipline equivalent RN R.Ph Pharm D degree highly preferred
- 8+ years proven pharmacovigilance experience preferably oncology
- Experience working safety scientific activities setting Product Safety Team/Safety Management Team model
- Experience Early Late Phase development clinical trials safety surveillance signal detection processes
- High EQ demonstrated skills experience fostering positive culture within PV organization
- General knowledge understanding US EU requirements e.g US Code Federal CFR regulations European Union EU Guideline Good Pharmacovigilance Practices GVP ICH Guidelines
- Experience extensive working knowledge MedDRA proprietary databases processes individual case medical review signal detection evaluation aggregate data assembly review reporting well clinical study management
- Experience compilation writing reviewing documents such DSURs IB PBRERs/PADER responses Health Authority requests submission documents labels
- Previous MAA/BLA experience including contributing preparation authoring related aspects Common Technical Document
- Experience audits inspection Strong relationship building skills ability interact effectively multifunctional multicultural growing organization Strategic thinking strong organizational analytic skills project management excellent verbal written communication attention detail
Benefits
Our Offer
We offer an exciting opportunity work some best brightest biotech industry . As part Merus you’ll chance collaborate exceptional international team people passionate what they do . To top it off we offer highly competitive total rewards package benefits compensation training tailored your individual development career opportunities match your ambitions . Most importantly you’ll chance help us close on cancer – everything you do matters at Merus .
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